AccessGUDID - DEVICE: Sunquest Mitogen LIMS (B236LIMS3500)

GUDID

Device Identifier (DI) Information

Brand Name: Sunquest Mitogen LIMS
Version or Model: 3.5
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CliniSys, Inc

Primary DI Number: B236LIMS3500
Issuing Agency: HIBCC
Commercial Distribution End Date: January 25, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 052934841 *Terms of Use

Device Description: Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory workflow (order entry through reporting) and to transfer, store, and display test results and information.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44082	Clinical laboratory information system application software	An application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with clinical laboratory services and facilities. It is typically supplied for installation into a dedicated information system used in the clinical laboratory or existing mainframe or decentralized computers/networks.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JQP	Calculator/Data Processing Module, For Clinical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7b6b327c-42ce-4df9-ab97-4eb3f3d573ef
Public Version Date: July 24, 2023
Public Version Number: 3
DI Record Publish Date: July 02, 2021